Surgical Stapling Instruments Structured for Delivery of Medical Agents

ABSTRACT

A medical agent dispensing system can be provided that may be structured for use with a surgical severing/stapling instrument that is designed for severing and stapling tissue. The dispensing system may include at least one storage reservoir structured for storing at least a component of a medical agent; a gear pump casing in communication with the storage reservoir; a screw pump auger positioned within the gear pump casing capable of rotational manipulation to move the medical agent through the gear pump casing; and, at least one agent tube in communication with the gear pump casing. The agent tube may be structured for communication with a least one agent port formed in a staple cartridge of the surgical instrument for dispensing the medical agent therethrough.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. Ser.No. 11/267,811 filed on Nov. 4, 2005.

FIELD OF THE INVENTION

The present invention generally relates to surgical instruments. Theinvention more particularly relates to delivery and application ofmedical agents in association with the use of surgical instruments topromote closure and healing of severed and stapled tissue.

BACKGROUND

Conventional surgical staplers that can be used to simultaneously makelongitudinal incisions in tissue and apply lines of staples on opposingsides of the incisions are known in the art. Such instruments commonlyinclude a pair of cooperating jaw members that, when employed inendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members typically receives a staplecartridge having at least two laterally spaced rows of staples. Theother jaw member defines an anvil having staple-forming pocketscorrespondingly aligned with the rows of staples in the cartridge. Suchstapling instruments may also include a plurality of reciprocatingwedges that pass through openings in the staple cartridge when drivenand engage drivers supporting the staples to effect the firing of thestaples toward the anvil and through tissue.

Examples of surgical staplers suitable for use with endoscopicapplications are described in U.S. Patent Application No. US2004/0232196 A1. In operation of the surgical stapler, a cliniciancloses or clamps the jaw members of the stapler on tissue to positionthe tissue prior to firing or activation of the stapler. Once theclinician has determined that the jaw members are clamping the tissue ina desired position, then the surgical stapler can be fired by theclinician to create an incision in the tissue and at the same timestaple tissue surrounding the incision. This simultaneous action of thestapler avoids complications that often arise when the severing andstapling operations are performed sequentially (or at different times)with different surgical tools (i.e., one device is used to sever thetissue, and then another device is used to staple the tissue).

In general, application of certain medical agents to tissue incisionscan promote healing, reduce the possibility of infection, and/or promoteproper sealing of the incisions. If assisted by the action of suchmedical agents, many surgical staplers could achieve better surgicalresults with respect to enhanced healing, improved infection resistance,and improved sealing of tissue incisions. However, the structure of manyconventional surgical staplers, and the procedures in which suchstaplers are employed, do not leverage the benefits of medical agents orsystems that dispense medical agents.

In view of the foregoing, there is a need for improved surgicalinstruments and medical agent dispensing systems than can moreeffectively and efficiently promote closure, treatment, and healing oftissue incisions severed and stapled during operations involvingsurgical staplers.

SUMMARY

In accordance with the present invention, various embodiments of amedical agent dispensing system can be provided. The medical agentdispensing system may be structured for use with a surgicalsevering/stapling instrument structured for severing and staplingtissue. The dispensing system may include: at least one storagereservoir structured for storing at least a component of a medicalagent; a gear pump casing in communication with the storage reservoir; ascrew pump auger positioned within the gear pump casing capable ofrotational manipulation to move the medical agent through the gear pumpcasing; and, at least one agent tube in communication with the gear pumpcasing. The agent tube may be structured for communication with a leastone agent port formed in a staple cartridge of the surgical instrumentfor dispensing the medical agent therethrough.

In accordance with the invention, various embodiments of a surgicalsevering/stapling instrument including a medical agent dispensing systemcan be provided. The surgical instrument may include a handle portionincluding at least one storage reservoir structured for storing at leasta component of a medical agent, and a shaft portion connected to thehandle portion. The shaft portion may include a gear pump casing incommunication with the storage reservoir, wherein the gear pump casingincludes a screw pump auger extending therethrough capable of rotationalmanipulation to move the medical agent through the gear pump casing. Thesurgical instrument may also include an end effector portion operativelyassociated with the shaft portion that has a staple cartridge positionedremovably therein. At least one agent tube may be provided incommunication with the gear pump casing; and the agent tube may extendfrom the shaft portion to communicate with a least one agent port formedin the staple cartridge of the surgical instrument. The agent port maybe structured to permit the medical agent to be dispensed therethrough.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated into and constitute apart of this specification, illustrate embodiments of the invention.Together with the description of the embodiments provided herein, thedrawings serve to explain the principles of the present invention forthose skilled in the art.

FIG. 1 depicts an three-dimensional, partially cut-away, partiallyschematic view of a surgical instrument that may be provided inassociation with embodiments of a medical agent dispensing system inaccordance with the present invention;

FIG. 2 illustrates a disassembled, three-dimensional view of the endeffector and a shaft portion of the surgical instrument of FIG. 1;

FIG. 3 includes schematic depictions of handle, shaft and end effectorportions of the surgical instrument of FIG. 1;

FIG. 4 includes an enlarged view of the shaft and end effector portionsof the surgical instrument of FIG. 3;

FIG. 5 includes a enlarged view of the shaft and handle portions of thesurgical instrument of FIG. 3;

FIG. 6 includes an enlarged, three-dimensional view of a screw pumpauger that may be employed in accordance with various embodiments of theinvention;

FIG. 7 includes an enlarged, partially cut-away, three-dimensional viewof a portion of the instrument of FIG. 1;

FIG. 8 includes an end view of the channel of the surgical instrument ofFIG. 2; and,

FIG. 9 includes a process flow diagram illustrating various aspects ofan example of a method for using embodiments of the medical agentdispensing system of the present invention.

DESCRIPTION

As applied herein, the term “tissue” may include a variety of human oranimal tissues, membranes, or other organic substrates. The term“tissue” may also include any substance, substrate, or composition ofmatter capable of being severed and stapled by the various embodimentsof surgical stapling/severing instruments described herein.

As applied herein, the term “medical agent” may include a variety ofchemicals, liquids, high viscosity fluids, powders or other compositionsof matter that may be applied to tissues. Examples of “medical agents”include, without limitation, hemostatic agents, healing agents,adhesives, sealants, antibacterial agents, infection-resistant agents,analgesics, and various other kinds of medicinal or beneficialsubstances.

With general reference to the figures, and in association with variousembodiments of the invention, a surgical severing/stapling instrument 10may be structured with a handle portion 20 that is connected to animplement portion 22. The implement portion 22 may include a shaft 24which extends distally from the handle portion 20 and terminates in anend effector 26. The end effector 26 may include an actuator or E-beamfiring mechanism (“firing bar”) 28 that controls spacing between anelongated channel 30 and a pivotally translatable anvil 32 includedwithin the end effector 26. It can be seen that the spacing between thechannel 30 and the anvil 32 may be configured to promote effectivestapling and severing of tissue during use of the surgical instrument 10by a clinician, for example.

The handle portion 20 of the instrument 10 may include a pistol grip 34toward which a closure trigger 36 may be pivotally drawn by theclinician, for example, to cause clamping or closing of the anvil 32toward the channel 30 of the end effector 26. In operation, the tissueof a patient, for example, may be clamped by the closing of the anvil 32toward the channel 30. A firing trigger 38 positioned adjacent to theclosure trigger 36 can be pivotally drawn in the direction of the pistolgrip 34 to substantially simultaneously staple and sever tissue clampedin the end effector 26 of the instrument 10. In a surgical operation,the clinician first activates the closure trigger 36 to clamp the tissueof a patient, for example. Once the clinician is satisfied with thepositioning of the end effector 26, the closure trigger 36 may be drawnback to a fully closed and locked position proximate to the pistol grip34. The firing trigger 38 of the instrument 10 may then be actuated tosever and staple the clamped tissue. The firing trigger 38 mayspringedly return to a normal, inactivated state when the clinicianremoves pressure applied to the firing trigger 38. A release button 40positioned on the proximal end of the handle portion 20 may be pressedby the clinician to release the locked closure trigger 36 to itsnormally open position (as shown in FIG. 1).

In various embodiments, the distal end of the shaft 24 may include aclosure tube 52 structured to receive and contain portions of thecomponents of the end effector 26, such as the anvil 32 and the channel30. The closure tube 52 may also be structured to receive a spine 54extending therethrough that supports a knife shaft 56 having a distallypositioned severing edge 58. The knife shaft 56 may operatively interactwith the firing bar 28 at the severing edge 58 of the knife shaft 56. Aknife spring 60 may be inserted within the spine 54 and structured witha resilient downward bias that promotes proper and secure positioning ofthe knife shaft 56 within the spine 54. In operation, when theinstrument 10 is fired, the knife shaft 56 and its severing edge 58 aremoved through the channel 30 by a knife rod 61 to sever tissue clampedbetween the anvil 32 and the channel 30. The channel 30 may bestructured to receive a removable staple cartridge 62 therein. Thestaple cartridge 62 may have multiple staple holes (such asillustratively representative staple holes 64, 66, 68) formed thereinand through which multiple staples (not shown) may be driven that staplesevered tissue when the instrument 10 is fired. In certain embodiments,the staple cartridge 62 may be an “ETS45” or “ETS60” six-row cartridge,for example, marketed by Ethicon Endo-Surgery, Inc., of Cincinnati,Ohio.

Examples of the structure and operation of typical surgical staplinginstruments that may be provided in association with embodiments of thepresent invention are disclosed in a United States published patentapplication to Shelton et al. entitled, “Surgical Stapling Instrumenthaving Separate Distinct Closing and Firing Systems” (U.S. Pub. No.2004/0232196, Ser. No. 10/441,632, filed on May 20, 2003), the entiretyof which is hereby incorporated by reference.

With regard to embodiments of a medical agent dispensing system that maybe provided in conjunction with the surgical instrument 10, a gear pumpcasing 72 may be positioned to extend longitudinally through the spine54, and may extend from the handle portion 20 of the instrument 10 to alateral manifold 74. The gear pump casing 72 may be structured toreceive therethrough a screw pump auger 76 that is capable of rotationalmanipulation when positioned within the gear pump casing 72. FIG. 6shows an example of a screw pump auger 76 that may be used in accordancewith various embodiments of the invention. One or more agent tubes 78,80 may be positioned to communicate both with the lateral manifold 74and with a plurality of agent ports (such as illustrativelyrepresentative agent ports 82, 84, 86) formed in the staple cartridge 62generally adjacent to the staple holes 64, 66, 68 of the cartridge 62.The agent tubes 78, 80 may be structured for communication with theagent ports 82, 84, 86 in the staple cartridge 62 as shown in the endview of the cartridge 62 of FIG. 8. While a row of agent ports 82, 84,86 is shown positioned next to both sides of a longitudinal center lineof the channel 30, it can be appreciated that more or less such agentports 82, 84, 86 may be provided in the cartridge 62. For example, moreagent ports 82, 84, 86 may be provided in place of one or more of thestaple holes 64, 66, 68 formed in the cartridge 62 as shown. Withparticular reference to FIGS. 3 and 5, one or more structures such asmounting blocks 79, 81 may be included within the channel 30 tofacilitate securement and stability of the agent tubes 78, 80(respectively) within the instrument 10. Also, it can be seen that theagent tubes 78, 80 (such as the left-hand side agent tube 78, as shownin FIG. 4, for example) may be positioned generally adjacent to theknife shaft 56 as the agent tubes 78, 80 extend longitudinally throughthe shaft 24.

In various embodiments, the handle portion 20 may include one or moremedical agent storage reservoirs 92, 94 mounted on the handle portion 20and in communication with the casing 72. The storage reservoirs 92, 94may contain a variety of medical agents, or components thereof, that canbe beneficially applied to severed and stapled tissue by action of thedispensing system in connection with use of the surgical instrument 10.While multiple storage reservoirs 92, 94 are depicted with theinstrument 10 for convenience of disclosure, certain embodiments of theinvention may employ only a single storage reservoir or more than twostorage reservoirs. It can be seen that employing multiple storagereservoirs 92, 94 can facilitate real-time mixing of multiple-componentmedical agents during operation of the medical agent dispensing system.For example, one storage reservoir 92 may contain a powder and the otherstorage reservoir 94 may contain a liquid. The powder and the liquid inthe storage reservoirs 92, 94 may be mixed during operation of theinstrument 10, such as by directing the substances through theY-manifold 96 (as shown in FIGS. 3 and 5, for example). It can beappreciated that storing and deploying components of a medical agentseparately may preserve the shelf life and thus the effectiveness of theindividual components. In another example, the use of multiple storagereservoirs 92, 94 permits the use of two-part adhesives, for example, inconnection with operation of the dispensing system within the instrument10.

Also, in various embodiments of the medical agent dispensing system ofthe present invention, an electric motor 98 may be included within thehandle portion 20 with a mechanical linkage structured to drive rotationof the screw pump auger 76 within the gear pump casing 72 uponactivation of the motor 98. Those skilled in the art will appreciatethat the electric motor 98 may be any conventional battery-driven orAC-powered motor provided with specifications (e.g., a motor rating)suitable for safe and effective use of the motor 98 in association withoperation of the surgical instrument 10. In certain embodiments, theelectric motor 98 may be activated through conventional electricalcircuitry or components 100 that can be operatively associated with thefiring trigger 38, the release button 40, and/or an independent manualactivation switch 102 of the instrument 10. The electrical circuitry 100may be configured to activate the motor 98 automatically in associationwith the firing operation of the instrument 10, for example; and/or toactivate the motor 98 manually through use of the switch 102 which maybe pressed by the clinician, for example, when using the instrument 10.In certain embodiments, a mechanically driven rotary trigger, forexample, may be configured to interact with the mechanical linkageoperatively associated with the casing 72 to drive rotation of the screwpump auger 76 within the casing 72.

With reference to FIG. 9, a process flow diagram illustrates a method ofapplying the instrument 10 with the medical agent dispensing system in asurgical procedure performed on tissue, in accordance with variousembodiments of the invention. At step 202, the instrument 10 may befired as described above to sever tissue and to apply staples to areason both sides of an incision made in the tissue. At step 204, inconnection with retraction of the knife shaft 56 from thesevered/stapled tissue, the electric motor 98 may be activated toinitiate rotation of the screw pump auger 76 within the gear pump casing72 at step 206. At step 208 (which may occur substantially in parallelwith step 206), the gear pump casing 72 receives a quantity of a medicalagent, or components combined to create a quantity of the medical agent,from the Y-manifold 96. At step 210, the medical agent is delivered byrotational action of the screw pump auger 76 to the lateral manifold 74.At step 212, the medical agent may be driven through the agent tubes 78,80 to be dispensed at step 214 through the plurality of agent ports 82,84, 86 in the staple cartridge 62. Once dispensed through the pluralityof agent ports 82, 84, 86, the medical agent may then cover or deluge atleast a portion of tissue areas severed and stapled by action of theinstrument 10 at step 202.

It will be appreciated that the terms “proximal” and “distal” may beused herein as convenient terms of relative orientation, such as withreference to a clinician gripping a handle of an instrument. Forexample, the end effector 26 may be considered “distal” with respect tothe “proximal” handle portion 20 (see, e.g., FIG. 1). It will be furtherappreciated that, for convenience and clarity of disclosure, spatialterms of relative orientation such as “vertical” and “horizontal” or“downward” and “upward” may be used herein with respect to the drawings.Those skilled in the art will appreciate, however, that surgicalinstruments may be used in many orientations and positions, and suchterms are not intended to be limiting and absolute.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein is done soonly to the extent that the incorporated material does not conflict withexisting definitions, statements, or other disclosure material set forthin the present disclosure. As such, and to the extent necessary, thedisclosure as explicitly set forth herein supersedes any conflictingmaterial incorporated herein by reference. Any material, or portionthereof, that is said to be incorporated by reference herein, but whichconflicts with existing definitions, statements, or other disclosurematerial set forth herein will only be incorporated to the extent thatno conflict arises between that incorporated material and the existingdisclosure material.

The examples presented herein are intended to illustrate potential andspecific implementations of the present invention for those skilled inthe art. No particular aspect or aspects of the examples included hereinare necessarily intended to limit the scope of the present invention.

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for purposes of clarity, other elements. Those of ordinary skill in theart will recognize, however, that these and other elements may bedesirable in a typical computer system or database system. However,because such elements are well known in the art and because they do notfacilitate a better understanding of the present invention, a discussionof such elements may not be provided herein.

Any element expressed herein as a means for performing a specifiedfunction is intended to encompass any way of performing that functionincluding, for example, a combination of elements that perform thatfunction. Furthermore the invention, as defined by suchmeans-plus-function claims, resides in the fact that the functionalitiesprovided by the various recited means are combined and brought togetherin a manner as defined by the appended claims. Therefore, any means thatcan provide such functionalities may be considered equivalents to themeans shown herein.

In various embodiments of the present invention disclosed herein, asingle component may be replaced by multiple components, and multiplecomponents may be replaced by a single component, to perform a givenfunction or functions. Except where such substitution would not beoperative to practice embodiments of the present invention, suchsubstitution is within the scope of the present invention.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. The present invention hasbeen discussed in terms of endoscopic procedures and apparatus. However,use herein of terms such as “endoscopic” should not be construed tolimit the present invention to a surgical stapling and severinginstrument for use only in conjunction with an endoscopic tube (i.e.,trocar). On the contrary, it is believed that surgical instrumentsstructured in accordance with the present invention may find use in manysurgical procedures, including but not limited to laparoscopicprocedures and open procedures. Moreover, the unique and novel aspectsof the embodiments of the present invention may find utility when usedin connection with other forms of stapling apparatuses without departingfrom the spirit and scope of the present invention.

1. A medical agent dispensing system structured for use with a surgicalsevering/stapling instrument structured for severing and staplingtissue, the dispensing system comprising: at least one storage reservoirstructured for storing at least a component of a medical agent; a gearpump casing in communication with the storage reservoir; a screw pumpauger positioned within the gear pump casing, the screw pump auger beingcapable of rotational manipulation to move the medical agent through thegear pump casing; and, at least one agent tube in communication with thegear pump casing, the agent tube being structured for communication withat least one agent port formed in a staple cartridge of the surgicalinstrument for dispensing the medical agent therethrough.
 2. Thedispensing system of claim 1, wherein the medical agent includes ahemostatic agent.
 3. The dispensing system of claim 1, wherein themedical agent includes an adhesive.
 4. The dispensing system of claim 1,wherein the gear pump casing is positioned to extend longitudinallythrough a spine of the surgical instrument.
 5. The dispensing system ofclaim 1, wherein the gear pump casing is in communication with the agenttube through a lateral manifold.
 6. The dispensing system of claim 5,wherein the agent tube is in communication with both the lateralmanifold and a plurality of the agent ports.
 7. The dispensing system ofclaim 1, further comprising at least a second agent tube incommunication with the gear pump casing, wherein the first agent tubecommunicates with a first plurality of agent ports formed in the staplecartridge, and the second agent tube communicates with a secondplurality of agent ports formed in the staple cartridge.
 8. Thedispensing system of claim 1, further comprising at least one agent portbeing formed generally adjacent to at least one staple hole of thestaple cartridge.
 9. The dispensing system of claim 1, furthercomprising at least a second storage reservoir in communication with thegear pump casing, the second storage reservoir being structured forstoring at least a component of the medical agent.
 10. The dispensingsystem of claim 9, wherein the component stored in the first storagereservoir and the component in the second storage reservoir are designedto be combined to form the medical agent.
 11. The dispensing system ofclaim 9, further comprising a Y-manifold in communication with both thefirst storage reservoir and the second storage reservoir.
 12. Thedispensing system of claim 1, further comprising an electric motorstructured to drive rotation of the screw pump auger within the gearpump casing.
 13. The dispensing system of claim 1, further comprising amechanically driven rotary trigger configured to drive rotation of thescrew pump auger within the gear pump casing.
 14. A surgicalsevering/stapling instrument including a medical agent dispensingsystem, the instrument comprising: a handle portion including at leastone storage reservoir structured for storing at least a component of amedical agent; a shaft portion connected to the handle portion, theshaft portion including a gear pump casing in communication with thestorage reservoir, the gear pump casing including a screw pump augerextending therethrough capable of rotational manipulation to move themedical agent through the gear pump casing; an end effector portionoperatively associated with the shaft portion, the end effectorincluding a channel having a staple cartridge positioned removablytherein; at least one agent tube in communication with the gear pumpcasing, the agent tube extending from the shaft portion to communicatewith at least one agent port formed in the staple cartridge fordispensing the medical agent therethrough.
 15. The instrument of claim14, wherein the medical agent includes a hemostatic agent.
 16. Theinstrument of claim 14, wherein the medical agent includes an adhesive.17. The instrument of claim 14, wherein the gear pump casing is incommunication with the agent tube through a lateral manifold.
 18. Theinstrument of claim 14, further comprising at least a second agent tubein communication with the gear pump casing, wherein the first agent tubecommunicates with a first plurality of agent ports formed in the staplecartridge, and the second agent tube communicates with a secondplurality of agent ports formed in the staple cartridge.
 19. Theinstrument of claim 14, further comprising the handle portion includingat least a second storage reservoir in communication with the gear pumpcasing, the second storage reservoir being structured for storing atleast a component of the medical agent.
 20. The instrument of claim 19,wherein the component stored in the first storage reservoir and thecomponent in the second storage reservoir are designed to be combined toform the medical agent.